CN113262255A - Traditional Chinese medicine composition for treating infantile eczema, preparation method and application thereof - Google Patents

Abstract

The application relates to a traditional Chinese medicine composition for treating infantile eczema, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating infantile eczema comprises cortex dictamni, fructus kochiae, fructus forsythiae, lonicerae flos, cortex phellodendri, dandelion and centipedes; wherein cortex Dictamni Radicis and Kochiae fructus are principal drugs; fructus forsythiae, flos lonicerae and cortex phellodendri are ministerial drugs; the dandelion is an adjuvant drug; scolopendra is used as messenger drug. The Chinese medicinal composition has effects of clearing heat, eliminating dampness, dispelling pathogenic wind and relieving itching, and can be used for preventing and treating infantile eczema. Compared with the existing medicine for treating infantile eczema, the traditional Chinese medicine composition is a pure traditional Chinese medicine preparation, has a good treatment effect, and can also avoid hormone medical problems caused by using chemical medicines.

Description

Traditional Chinese medicine composition for treating infantile eczema, preparation method and application thereof

Technical Field

The application relates to a traditional Chinese medicine composition for treating infantile eczema, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines.

Background

Infantile eczema, i.e. Atopic Dermatitis (AD), also known as atopic dermatitis and atopic dermatitis, is a chronic, recurrent and inflammatory skin disease. More than in infancy and extending to childhood and adulthood. The symptoms mainly include chronic and repeated pruritus, which affects sleep. Chronic recurrent dermatitis in the flexed side regions of the elbow and popliteal fossa is often characterized by erythema, followed by papules with dense granularities, papules or blisters with serous exudation and crusting. Acute eczema can be converted into subacute or chronic eczema due to improper treatment. Severe cases may develop erythema papule, herpes dunulae, blister, and subjective pruritus. Erosion and scabbing can occur when the affected part is scratched, pus exudation occurs under the scab, small pustules exist at the edge, and local lymph nodes are swollen and tender. The pathogenesis of the disease is not clear, and at present, the disease is considered to be related to genetic, environmental, immune and biological factors, wherein the genetic factors play an important role, and children with family history of allergic constitution are more likely to suffer from eczema. The main cause is intolerance or allergy to food, inhalants or contact products. Literature data show that the incidence rate of infantile eczema is 12% -25%, and the infantile eczema is in a rising trend year by year. The prevalence rate of children under 5 years old is 86.2% of total morbidity children, the incidence rate of male and female children is close, and allergic constitution children account for 33.3% of total morbidity children.

Eczema is well documented in ancient Chinese medical books, and is also discussed in relation to infantile eczema. The Ming dynasty doctors 'Chen Shi Gong' refers to infantile eczema as infantile eczema, as in Zhongyun from "orthodox surgery. infantile eczema": infantile eczema, which is in the fetus, five pungent food for mother and roasted for father meal, and infantile eczema which occurs all over the head and face after birth due to heat retention. The term "Yi Zong jin Jian" refers to infantile eczema as "fetal suppurative sore", which is originated from the vertex of the head or eyebrow of a baby and is also called mammary tinea ". Therefore, ancient physicians often included the record of infantile eczema in "sores", "ringworm" and "wind", and often called "sores" for erosive exudation, chronic ringworm "for chronic eczema, and" wind "for severe pruritus. Modern TCM refers to eczema as "eczema".

At present, modern western medicine takes external corticosteroids, calcineurin inhibitors, antibiotics and astringent antipruritic as main means for treating eczema; antihistamines, antibiotics, hormones, and immunosuppressants can be administered orally if necessary. However, for infantile eczema, both external and internal medicines are greatly limited, and the infantile eczema has the disadvantages of repeated attack after stopping taking the medicine, more adverse reactions caused by long-term frequent administration and the like.

In the prior art, a pure Chinese medicinal preparation is also used for treating infantile eczema, and the compound phellodendron bark liquid coating agent is a pure Chinese medicinal preparation, has good effects of resisting inflammation and infection and promoting wound healing, and can improve local microcirculation and promote granulation tissue growth. Although the compound phellodendron amurense liquid liniment has a certain treatment effect on infantile eczema, the compound phellodendron amurense liquid liniment can achieve a better treatment effect only by being combined with other glucocorticoids, for example, the effective rate of the compound phellodendron amurense liquid liniment for treating infantile eczema by combining butyric acid hydrogenation is 97.56%, and the recurrence rate is 7.32%; the effective rate of treating infantile eczema only by using butyric acid hydrogenation is 85.37%, the recurrence rate is 29.27%, but glucocorticoid is antibiotic, and the side effect is large.

If a pure traditional Chinese medicine composition can be developed, and the medicine can achieve good treatment effect only by using the medicine singly, the medicine is the key for preventing or treating infantile eczema.

Disclosure of Invention

In order to solve the problems, the invention provides a traditional Chinese medicine composition for treating infantile eczema, which has the effects of clearing heat, removing dampness, dispelling wind and relieving itching and can be used for preventing and treating infantile eczema. Compared with the existing medicine for treating infantile eczema, the traditional Chinese medicine composition is a pure traditional Chinese medicine preparation, has a good treatment effect, and can also avoid hormone medical problems caused by using chemical medicines.

The traditional Chinese medicine composition for treating infantile eczema comprises cortex dictamni, fructus kochiae, fructus forsythiae, lonicerae flos, cortex phellodendri, dandelion and centipedes; wherein cortex Dictamni Radicis and Kochiae fructus are principal drugs; fructus forsythiae, flos lonicerae and cortex phellodendri are ministerial drugs; the dandelion is an adjuvant drug; scolopendra is used as messenger drug.

Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:

30-90 parts of fructus forsythiae, 40-100 parts of cortex dictamni, 30-90 parts of fructus kochiae, 20-60 parts of lonicera confusa, 20-60 parts of dandelion, 20-60 parts of golden cypress and 1-10 parts of centipede.

Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:

40-80 parts of fructus forsythiae, 50-90 parts of cortex dictamni, 40-80 parts of fructus kochiae, 30-50 parts of lonicera confusa, 30-50 parts of dandelion, 30-50 parts of golden cypress and 1.5-4 parts of centipede.

Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:

50-80 parts of fructus forsythiae, 60-90 parts of cortex dictamni, 50-80 parts of fructus kochiae, 35-50 parts of lonicera confusa, 35-50 parts of dandelion, 35-50 parts of golden cypress and 2-4 parts of centipede.

Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:

60-80 parts of fructus forsythiae, 80-90 parts of cortex dictamni, 60-80 parts of fructus kochiae, 40-50 parts of lonicera confusa, 40-50 parts of dandelion, 40-50 parts of golden cypress and 2.4-4 parts of centipede.

Preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:

60 parts of fructus forsythiae, 80 parts of cortex dictamni, 60 parts of fructus kochiae, 40 parts of lonicera confusa, 40 parts of dandelion, 40 parts of golden cypress and 2.4 parts of centipede;

preferably, 80 parts of fructus forsythiae, 90 parts of cortex dictamni, 80 parts of fructus kochiae, 50 parts of lonicera confusa, 50 parts of dandelion, 50 parts of golden cypress and 4 parts of centipede;

preferably, 40 parts of fructus forsythiae, 50 parts of cortex dictamni, 40 parts of fructus kochiae, 30 parts of lonicera confusa, 30 parts of dandelion, 30 parts of golden cypress and 1.5 parts of centipede;

preferably, 50 parts of fructus forsythiae, 60 parts of cortex dictamni, 50 parts of fructus kochiae, 35 parts of lonicera confusa, 35 parts of dandelion, 35 parts of golden cypress and 2 parts of centipede.

According to another aspect of the present application, the above-mentioned Chinese medicinal composition can be prepared by the following method: water extraction, alcohol extraction, water extraction and alcohol precipitation, alcohol extraction and water precipitation, extraction, impregnation, percolation, reflux extraction, ultrasonic extraction, microwave extraction or macroporous resin adsorption.

The traditional Chinese medicine composition is preferably prepared by a water extraction method, and the preparation method comprises the following steps:

weighing the raw materials in parts by weight, adding water for extraction for 1-3 times, filtering, mixing filtrates, concentrating the filtrate to obtain fluid extract with relative density of 1.10-1.15 at 50 deg.C, adding ethanol to make alcohol content reach 70%, standing, refrigerating for 24 hr, and filtering to obtain extractive solution.

Preferably, the raw material medicines are weighed according to the parts by weight, water is added for extraction for 3 times, 4-8 times of water is added for decoction for 0.5-2h at the 1 st time, and the filtrate is filtered for standby; 2, adding 2-6 times of water for decocting for 0.5-5h, and filtering to obtain filtrate; decocting with 1-4 times of water for 0.5-2 hr for the 3 rd time, and filtering to obtain filtrate; mixing filtrates, and concentrating the filtrate at 50 deg.C to obtain fluid extract with relative density of 1.10-1.15; adding ethanol to make alcohol content reach 70%, standing, refrigerating for 24 hr, and filtering to obtain extractive solution.

According to another aspect of the application, the application provides the application of the traditional Chinese medicine composition and the traditional Chinese medicine composition prepared according to the preparation method in preparing a medicine for treating infantile eczema.

According to still another aspect of the present application, the present application provides a traditional Chinese medicine preparation for treating infantile eczema, which comprises the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method, and pharmaceutically acceptable auxiliary materials.

Preferably, the dosage form of the traditional Chinese medicine preparation is gel, ointment, cream, paste, oil, emulsion, tincture, aerosol, spray, liniment, patch, cataplasm or lotion; preferably, the traditional Chinese medicine preparation is gel, lotion, spray or ointment.

Preferably, the traditional Chinese medicine preparation is a gel, and the auxiliary materials of the gel comprise ethylparaben, propylene glycol and carbomer;

or the adjuvants include ethylparaben, propylene glycol, azone and carbomer;

or the adjuvants include sodium benzoate, glycerol and carbomer;

or the auxiliary materials comprise benzoic acid, glycerol and carbomer.

Preferably, the preparation method of the gel comprises the following steps:

taking 0.5-1.5g of ethylparaben, adding 25-75 g of propylene glycol to dissolve ethylparaben, mixing with the extracting solution of the traditional Chinese medicine composition, adding 7.5-22.5 g of carbomer, uniformly mixing, after complete swelling, adjusting the pH to 6.0-7.0 by using 10% triethanolamine solution, adding water to 500-1500 g, and uniformly stirring to obtain the gel.

Preferably, the preparation method of the gel comprises the following steps:

dissolving sodium benzoate 0.5g in glycerol 50g, mixing with the above Chinese medicinal extract, adding carbomer 10.0g, mixing, swelling completely, adjusting pH to 6.0-7.0 with 10% triethanolamine solution, adding water to 500g, and stirring.

Preferably, the preparation method of the gel comprises the following steps:

dissolving 0.5g benzoic acid, 50g glycerol and 7.5g azone, mixing with the above Chinese medicinal composition extractive solution, adding 10.0g carbomer, mixing, swelling completely, adjusting pH to 6.0-7.0 with 10% triethanolamine solution, adding water to 500g, and stirring.

The pharmacological actions of the traditional Chinese medicine raw materials used in the application are as follows:

dictamni Radicis, bitter, pungent, salty and cold in nature. Has effects of clearing heat, eliminating dampness, dispelling pathogenic wind, relieving itching, and removing toxic substance. It enters spleen, lung, small intestine, stomach and bladder meridians, and is good at removing dampness and dispelling wind, and also has the actions of inducing diuresis to remove damp-heat from the body. It is indicated for eczema, rubella, scabies, sore and other diseases caused by wind-heat damp toxin, and is the essential herb for treating itching sore due to damp-heat. The "herbal originality" is: the dittany bark enters the lung channel to remove wind and enter the small intestine channel to remove dampness, and the fu-feng shi removes wind-damp and blood-qi to activate and heat. "materia medica justice" also says: bai Xian is a bitter, cold and damp-clearing herb and can pass through the meridians of the tunnel. Therefore, the cortex dictamni can not only dispel wind-damp heat toxin, but also pass qi and blood, so that the itch and pain of the skin of a patient can be relieved automatically. Di Fu Zi is pungent, bitter and cold in nature. Has effects of clearing heat, promoting diuresis, dispelling pathogenic wind and relieving itching. It enters kidney and bladder meridians. The Dian nan Ben Cao says that the medicine has the effects of promoting urination and heat accumulation in the bladder, washing the wind of the skin, treating the exogenous pathogenic heat of all meridians of women, clearing heat in the fetus and eliminating damp-heat leukorrhagia. The original herbal medicine is also called as "removing accumulated heat in skin and eliminating dampness and itching except skin". It is indicated that it is indicated for eczema and its itching due to damp-heat, especially infantile eczema due to fetal toxicity, because it has actions of clearing heat and dispersing, it can dispel wind from the skin and clear damp-heat from the bladder. The cortex dictamni and the fructus kochiae have synergistic effect in compatibility, enhance the effects of clearing heat, eliminating dampness, dispelling wind and relieving itching, and have obvious curative effect on damp-heat type infantile eczema, so the cortex dictamni and the fructus kochiae are combined as monarch drugs.

Lian Qiao, bitter and slightly cold in flavor, enters lung, heart and small intestine meridians. Clear heat and remove toxicity, disperse wind-heat, resolve swelling and dissipate nodulation. Flos Lonicerae, cold in nature and sweet in taste, enters lung, heart and stomach meridians, and can disperse wind-heat, clear heat and remove toxicity. Both of them are fragrant, light and volatile, and often used in combination, they can double the actions of dispelling wind, clearing heat and removing toxicity. Huang Bai, bitter in taste and cold in nature, enters kidney and bladder meridians. Has effects of clearing heat, eliminating dampness, removing toxic substance, and treating sore, and can be used for treating eczema and damp-heat pyocutaneous disease. The three medicines are used as ministerial medicines to assist the monarch medicines in enhancing the effects of dispelling wind and removing dampness, and clearing heat and removing toxicity.

Dandelion, bitter, sweet and cold. Entering Yangming and Taiyin meridians, has the effects of clearing heat and removing toxicity, eliminating carbuncle and dissipating stagnation, has the effect of treating or preventing red swelling, dampness and erosion of the eczema sore surface, and is an adjuvant drug.

Centipede, pungent and warm; is toxic. Dispel wind and counteract toxic substance, dredge collaterals. The recipe takes the property of dredging collaterals, relieving depression, moving and leading channels as guiding drugs.

Benefits of the present application include, but are not limited to:

the traditional Chinese medicine composition for treating infantile eczema provided by the application is compatible in all medicines, and has the effects of clearing heat, eliminating dampness, dispelling wind and detoxifying together, so as to achieve the effects of removing heat and toxic materials, relieving itching and treating eczema; compared with the existing medicine for treating infantile eczema, the medicine composition is a pure traditional Chinese medicine preparation, and accords with the characteristics of three effects (high efficiency, quick effect and long effect), three small effects (small toxicity, small reaction and small dosage) and five convenience (production, transportation, use, carrying and storage) of the modern preparation; the hormone dependence problem caused by using chemical drugs can be avoided.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a graph showing a comparison of inflammatory conditions of the skin on the back of a mouse;

FIG. 2 is a graph of the number of scratches on day 8 after administration of the drug to mice;

FIG. 3 is a graph of the number of scratches on day 12 after administration of the drug to mice;

FIG. 4 is a graph of the number of scratches on day 16 after administration of the drug to mice;

FIG. 5 is a graph of the number of scratches on day 20 after administration of the drug to mice;

FIG. 6 is a comparison graph of swelling degree of mouse ear;

FIG. 7 is a comparison of H & E stained sections of mouse dorsal skin pathology;

FIG. 8 is a comparison of the thickness of the epidermis of the skin on the back of a mouse;

FIG. 9 is a graph showing a comparison of the number of lymphocytes and inflammatory cells in the skin of the back of a mouse.

Detailed Description

The present application will be described in detail with reference to examples, but the present application is not limited to these examples.

Examples 1 to 12

The method for preparing the extract of the chinese medicinal composition of examples 1 to 12 comprises the steps of:

extracting the Chinese medicinal composition with water for 3 times, decocting 1 time with 6 times of water for 1 hr, decocting 2 times of water for 4 times for 45 min, decocting 3 times with 2.5 times of water for 30 min, mixing filtrates, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.10-1.15(50 deg.C), adding ethanol to make ethanol content reach 70%, standing for 24 hr, filtering, concentrating the filtrate under reduced pressure to remove ethanol smell, adding water, stirring, standing, refrigerating for 24 hr, and filtering to obtain extractive solution.

The preparation method of the gel comprises the following steps:

dissolving ethylparaben in propylene glycol, mixing with the above extractive solution, adding carbomer, mixing, swelling completely, adjusting pH to 6.0-7.0 with 10% triethanolamine solution, adding water to a certain weight, and stirring to obtain gel.

Specific preparation conditions are shown in table 1.

TABLE 1 compounding ratio of the Chinese medicinal composition and adjuvants of the gel of examples 1-12

It is to be noted that the components of the Chinese medicinal composition of examples 1 to 3 are consistent; the components of the Chinese medicinal compositions of examples 4-6 are consistent; the components of the Chinese medicinal compositions of examples 7-9 are consistent; the components of the Chinese medicinal composition of examples 10-12 are consistent; comparative example 1 differs from example 2 in that centipedes are not included in the pharmaceutical composition; the traditional Chinese medicine composition of the comparative example 2 is a formula of a compound phellodendron bark liquid, and is different from the formula of the example 2 in that the traditional Chinese medicine composition does not contain cortex dictamni and fructus kochiae.

When a mouse is taken as a research object, the effective rate and the recurrence rate of the gel prepared in the examples 1-12 and the comparative examples 1-2 in treating infantile eczema are shown in a table 2.

TABLE 2 effective rate and recurrence rate of infantile eczema treatment with the gels of examples 1-12 and comparative examples 1-2

Sample numbering	Effective rate%	The recurrence rate%
			Example 1	98.3	5.1
Example 2	97.2	7.5
			Example 3	97.7	6.3
Example 4	81.2	12.5
			Example 5	83.5	13.1
Example 6	80.9	15.4
			Example 7	56.8	28.7
Example 8	54.6	26.9
			Example 9	53.7	30.01
Example 10	67.5	21.3
			Example 11	65.8	25.4
Example 12	66.9	23.8
			Comparative example 1	25.8	65.2
Comparative example 2	19.7	70.3

As can be seen from Table 2, the gels of examples 1-3 have relatively best therapeutic effect in treating infantile eczema; the gel of the embodiment 4 to 6 has relatively good treatment effect in the aspect of treating infantile eczema; the gels of examples 10-12 had relatively poor therapeutic efficacy in treating infantile eczema; the gels of examples 7-9 were the least effective in treating infantile eczema, and although examples 7-9 were the least effective in examples 1-12, the treatment of examples 7-9 was much better than comparative examples 1-2.

Compared with the examples 1-12, the comparison example 1 shows that the centipedes in the traditional Chinese medicine formula play an important role in treating the infantile eczema; compared with the examples 1-12, the comparative example 2 shows that the cortex dictamni and the fructus kochiae in the traditional Chinese medicine formula play an important role in treating the infantile eczema.

Pharmaceutical research

1. Experimental animals: 6-8 weeks spf BALB/c mice, 18-20g, female mice.

2. Experimental samples: the gels of examples 1-3, and the gels of comparative examples 1-2.

3. The experimental method comprises the following steps: the mice are randomly divided into a control group, a model group and a treatment group according to the body quality of the mice, the treatment group is divided into gel 1-5 groups (the gel prepared in examples 1-3 and the gel prepared in comparative examples 1-2 are used), the treatment group is administrated 2 times a day for 20 days continuously, and the gel 1-5 groups are administrated in the following modes: smearing with index finger for 2 times/day, 0.2-0.5 g/time, ensuring uniform smearing, covering and absorption; control mice used the same volume of phosphate buffered saline; the administration time is uniform and fixed every day.

Removing the back hair of the mouse 24h before molding by using a shaver and depilatory cream, wherein the hair removal area is about 2cm x2 cm; the mice in the model group and the treatment group were challenged by applying a 1% solution of DNCB (2, 4-dinitrochlorobenzene) topically to the hairless back of the mice on the first and third days of the experiment with 100ul of acetone and olive oil (acetone: olive oil 4:1, acetone and olive oil do not cause skin damage), and by applying 0.4% DNCB to the dorsal skin (100. mu.l) and the right ear (10. mu.l) of the mice every 3 days from the fifth day; the skin of the back and ear of control mice were topically applied with the same amount of acetone and olive oil (acetone: olive oil ═ 4:1) base. The treatment groups were administered continuously starting from the first day of molding (administration started after the excitation site was washed with physiological saline before the excitation day).

4. Observation indexes are as follows: swelling degree of ears of mice, skin lesion score, scratching times in ten minutes and pathological section of back skin.

The method specifically comprises the following steps: measuring the thickness of the ear by using a vernier caliper; evaluating the severity of dermatitis according to symptoms such as pruritus, erythema, erosion and edema; each symptom is classified as 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe); on day 21, the mice were sacrificed by dislocation, the dorsal skin was taken and fixed in 4% paraformaldehyde, HE stained, and the thickness of the skin lesion and the degree of inflammatory cell infiltration were observed.

5. The experimental results are as follows:

5.1 skin Damage score

As shown in FIG. 1, in the figure, Control is a Control group, Modle is a model group, HBL-gel1 is a gel1 group (applying the gel prepared in example 1), HBL-gel2 is a gel2 group (applying the gel prepared in example 2), HBL-gel3 is a gel3 group (applying the gel prepared in example 3), HBL-gel4 is a gel4 group (applying the gel prepared in comparative example 1), and HBL-gel5 is a gel5 group (applying the gel prepared in comparative example 2).

As can be seen from the figures, the skin of gel groups 1-3 had significantly reduced erythema, edema, and epidermal scaling and reduced skin keratinization, indicating that the gels of examples 1-3 were effective in relieving DNCB-induced skin inflammation; the gel 4-5 groups were less effective.

The components of the traditional Chinese medicine composition in the embodiment 1-3 are the same, the unit decoction piece content is gel1 group, gel2 group and gel3 group, the skin damage and edema of three groups of mice are obviously reduced, and the influence of the unit decoction piece content on the skin damage cannot be judged due to the large difference among mice; compared with the gel 1-3 groups, the gel4 group does not contain centipedes in the prescription, and has poor effect, so that centipedes are proved to be effective medicinal flavors and indispensable medicinal flavors in the prescription preliminarily; the gel5 group is a gel prepared from compound phellodendron bark liquid liniment, and compared with the formula of the gel 1-3 groups, the gel lacks broom cypress fruit and cortex dictamni, and has no obvious treatment effect on skin inflammation, and the broom cypress fruit and the cortex dictamni are proved to be effective medicines and are indispensable medicines in the formula.

5.2 mouse scratching times

As shown in fig. 2-5, it can be seen that at day 8, day 12 and day 16, gel3 group was the least, and at day 20, gel2 group and gel3 group were the least.

5.3 swelling degree of ear

As shown in fig. 6, the ears of the DNCB-treated model mice were significantly swollen and thickened, while the ear thickness of the treated group was significantly reduced, and the ears of the gel 1-3 and model groups were significantly thinned.

5.4 pathological section of skin

As shown in fig. 7-9, it can be seen from fig. 7 that the model group had a thickened skin, a local scab, a large number of dense cells in the scab lower layer, an enriched lymphocyte, a hyperplasia of sebaceous glands, a significantly thickened subcutaneous fat, and an increased number of inflammatory cells, compared to the control group; the skin layers of the gel 1-3 groups have no scabs and abscesses, the skin thickness of the back is thin (see figure 8), the inflammatory cells and lymphocytes are obviously reduced (see figure 9), and compared with the model group, the gel4 and the gel5 groups have disordered collagen fiber arrangement, sebaceous gland hyperplasia, more inflammatory cells, still more serious inflammation and little change.

As can be seen from the above data and pictures, gel 1-3 groups were effective in alleviating DNCB-induced specific skin damage. It can be seen from skin lesions on the backs of the mice that the mice treated with the gels of examples 1-3 had a significant reduction in erythema, skin lesions and edema, a significant reduction in ear thickness compared to the model group, and a significant reduction in the number of scratching behaviors due to itching and skin lesions. The gel 4-5 groups have poor effect, so the centipede, the broom cypress fruit and the cortex dictamni in the prescription are necessary medicinal flavors.

As can be seen by H & E staining pathomorphological analysis of the dorsal skin of mice, the DNCB-treated model group exhibited typical clinical features of dermatitis, such as hyperkeratinization, epidermal thickening and infiltration of immune cells. The tissues of the epidermis and the dermis of the mice treated by the gel 1-3 groups are obviously thinner than those of the mice in the model group, and the infiltrated inflammatory cells are also obviously reduced. In summary, the gels prepared in examples 1-3 partially alleviated DNCB-induced skin inflammatory lesions, with the best results obtained with the gel prepared in example 1.

Examples 13 to 15

Effect of the preparation method of the gel on the therapeutic Effect

The components of the traditional Chinese medicine composition used in the embodiments 13 to 15 are 60g of fructus forsythiae, 80g of cortex dictamni, 60g of fructus kochiae, 40g of lonicera confusa, 40g of dandelion, 40g of cortex phellodendri and 2.4g of centipede; preparation method of Chinese medicinal extractive solution referring to preparation methods of examples 1-12;

a method for preparing a gel comprises

Step 1, adding propylene glycol into ethylparaben, dissolving, and uniformly mixing with the extracting solution;

and 2, adding carbomer, mixing uniformly, adjusting the pH value to 6.0-7.0 by using 10% triethanolamine solution after complete swelling, adding water to 500g, and stirring uniformly to obtain the gel.

Wherein the auxiliary materials used in step 1 are different in composition, and ethylparaben, propylene glycol and carbomer are used in example 1; example 13 use of ethylparaben, propylene glycol, azone and carbomer; example 14 use of sodium benzoate, glycerin and carbomer; example 15 uses benzoic acid, glycerin, azone, and carbomer in the specific amounts shown in table 3.

Table 3.

Examples

Hydroxyphenyl Ethyl ester

Propylene glycol

Sodium benzoate

Benzoic acid

Glycerol

Azone compounds

Carbomer

1

0.5g

25g

0g

0g

0g

0g

7.5g

13

0.5g

25g

0g

0g

0g

7.5g

7.5g

14

0g

0g

0.5g

0g

50g

0g

10.0g

15

0g

0g

0g

0.5g

50g

7.5g

10.0g

The effective rate and recurrence rate of the preparation method of different gels in examples 1 and 13-15 for treating infantile eczema by using mice as a research object are shown in table 4.

Table 4 the method of preparing the gel of example 1, examples 13-15 has effective rate and recurrence rate for treating infantile eczema

Examples	Effective rate%	The recurrence rate%
			1	98.3	5.1
13	97.4	6.9
			14	95.9	7.8
15	96.1	7.9

As can be seen from tables 3 and 4, in the case that the formulation components of the Chinese medicinal composition are consistent, different excipients are used to prepare the gel, and the excipients have certain influence on the treatment effect of infantile eczema, but the influence is not particularly large, wherein when ethylparaben, propylene glycol and carbomer are used as the excipients, the effect of treating infantile eczema is relatively optimal.

The above description is only an example of the present application, and the protection scope of the present application is not limited by these specific examples, but is defined by the claims of the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the technical idea and principle of the present application should be included in the protection scope of the present application.

Claims (10)

1. A traditional Chinese medicine composition for treating infantile eczema is characterized by comprising cortex dictamni, fructus kochiae, fructus forsythiae, lonicera confusa, golden cypress, dandelion and centipedes.

2. The traditional Chinese medicine composition for treating infantile eczema as claimed in claim 1, which is characterized by comprising the following raw material medicines in parts by weight:

30-90 parts of fructus forsythiae, 40-100 parts of cortex dictamni, 30-90 parts of fructus kochiae, 20-60 parts of lonicera confusa, 20-60 parts of dandelion, 20-60 parts of golden cypress and 1-10 parts of centipede.

3. The traditional Chinese medicine composition for treating infantile eczema as claimed in claim 1, which is characterized by comprising the following raw material medicines in parts by weight:

40-80 parts of fructus forsythiae, 50-90 parts of cortex dictamni, 40-80 parts of fructus kochiae, 30-50 parts of lonicera confusa, 30-50 parts of dandelion, 30-50 parts of golden cypress and 1.5-4 parts of centipede.

4. The traditional Chinese medicine composition for treating infantile eczema as claimed in claim 1, which is characterized by comprising the following raw material medicines in parts by weight:

50-80 parts of fructus forsythiae, 60-90 parts of cortex dictamni, 50-80 parts of fructus kochiae, 35-50 parts of lonicera confusa, 35-50 parts of dandelion, 35-50 parts of golden cypress and 2-4 parts of centipede.

5. The traditional Chinese medicine composition for treating infantile eczema as claimed in claim 1, which is characterized by comprising the following raw material medicines in parts by weight:

60 parts of fructus forsythiae, 80 parts of cortex dictamni, 60 parts of fructus kochiae, 40 parts of lonicera confusa, 40 parts of dandelion, 40 parts of golden cypress and 2.4 parts of centipede;

or 80 parts of fructus forsythiae, 90 parts of cortex dictamni, 80 parts of fructus kochiae, 50 parts of lonicera confusa, 50 parts of dandelion, 50 parts of golden cypress and 4 parts of centipede;

or 40 parts of fructus forsythiae, 50 parts of cortex dictamni, 40 parts of fructus kochiae, 30 parts of lonicera confusa, 30 parts of dandelion, 30 parts of golden cypress and 1.5 parts of centipede;

or 50 parts of fructus forsythiae, 60 parts of cortex dictamni, 50 parts of fructus kochiae, 35 parts of lonicera confusa, 35 parts of dandelion, 35 parts of golden cypress and 2 parts of centipede.

6. The use of the Chinese medicinal composition according to any one of claims 1 to 5 in the preparation of a medicament for treating infantile eczema.

7. A traditional Chinese medicine preparation for treating infantile eczema, which is characterized by comprising the traditional Chinese medicine composition as claimed in any one of claims 1 to 5 and pharmaceutically acceptable auxiliary materials.

8. The Chinese medicinal preparation according to claim 7, wherein the Chinese medicinal preparation is in the form of a gel, an ointment, a cream, a paste, an oil, an emulsion, a tincture, an aerosol, a spray, a varnish, a patch, a cataplasm or a lotion; preferably, the traditional Chinese medicine preparation is gel, lotion, spray or ointment.

9. The Chinese medicinal preparation as claimed in claim 8, wherein the Chinese medicinal preparation is a gel, and its adjuvants include ethylparaben, propylene glycol and carbomer;

or the adjuvants include ethylparaben, propylene glycol, azone and carbomer;

or the adjuvants include sodium benzoate, glycerol and carbomer;

or the auxiliary materials comprise benzoic acid, glycerol and carbomer.

10. The method for preparing a Chinese medicinal preparation according to claim 9, comprising the steps of:

taking 0.5-1.5g of ethylparaben, adding 25-75 g of propylene glycol to dissolve ethylparaben, mixing with the extracting solution of the traditional Chinese medicine composition, adding 7.5-22.5 g of carbomer, uniformly mixing, after complete swelling, adjusting the pH to 6.0-7.0 by using 10% triethanolamine solution, adding water to 500-1500 g, and uniformly stirring to obtain the gel.

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